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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004861
Receipt No. R000005784
Scientific Title Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Date of disclosure of the study information 2011/01/12
Last modified on 2011/01/12

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Basic information
Public title Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Acronym Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Scientific Title Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Scientific Title:Acronym Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Region
Japan

Condition
Condition Non-muscle invasive bladder cancer (pTa-1, G1-2)
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The recurrence-preventive effects and safety of intravesical infusion therapy administered immediately after TUR-Bt of THP (within 24 hours) and additional maintenance therapy will be investigated in patients with low- and intermediate-risk non-muscle invasive bladder cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Recurrence-free rate (survival period and rate) (investigation in all patients, by risk (low and intermediate), and time (at 1, 2, and 3 years))
Key secondary outcomes Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pirarubicin (THP) at 30 mg will be infused into the urinary bladder for about 30 minutes within 24 hours after TUR-Bt in both groups.
Group A: The course will be observed.
Interventions/Control_2 Group B: THP at 30 mg will be infused into the urinary bladder once a week 9 times.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Non-muscle invasive bladder cancer (pTa-1,G1-2).
(2) Patients who can periodically undergo cystoscopic diagnosis of recurrence after surgery.
(3) Curative resection of all visible tumors can be performed.
(4) Agreement form for this study should be obtained from the patient.
Key exclusion criteria (1) Patients who previously underwent intravesical infusion therapy with BCG.
(2) Patients who underwent maintenance intravesical infusion therapy with anticancer drugs within 1 year.
(3) Patients with history or present disease of upper urinary tract utotherial carcinoma. (4) Patients with duplex of active other malignant disease.
(5) Function of all organs are without severe dysfunction.
(6) Inappropriate patients for this study judged by the physicians.
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Mikami
Organization Kyoto Prefectural University of Medicine
Division name Department of Urology
Zip code
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 075-251-5595
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Mikami
Organization Kyoto Prefectural University of Medicine
Division name Department of Urology
Zip code
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 075-251-5595
Homepage URL
Email info@kpum-urology.jp

Sponsor
Institute Department of Urology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor KPUM-Oncology Study Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都府立医科大学附属病院(京都府)、松下記念病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2015 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 12 Day
Last modified on
2011 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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